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A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
RecruitingPhase 3
Sponsor: German CLL Study Group
Conditions: Chronic Lymphocytic Leukemia
Interventions: Obinutuzumab, Venetoclax, Acalabrutinib
Countries: Germany
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).
Eligibility overview
Sex: ALL
Age: 18 Years to 120 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Documented CLL/SLL requiring treatment according to iwCLL criteria * Age at least 18 years * At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status. * Life expectancy ≥ six months * Adequate bone marrow function indicated by a platelet count \>30 x10\^9/l * Creatinine clearance ≥ 30ml/min * Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome * Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee * ks prior to registration for study screening (i.e. PCR only required when serology was positive)) * ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2 Exclusion Criteria: * Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted) * Absence of high risk disease (17p-deletion, TP53-mutation complex karyotype * An individual organ/system impairment score of 4 as assessed by the CIRS definition (e.g. advanced cardiac disease (NYHA class 3 or 4) limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract) * Transformation of CLL (Richter transformation) * Malignancies other than CLL currently requiring systemic therapies * Uncontrolled or active infection of HIV/PML or any other active infection * Anticoagulant therapy with warfarin or phenoprocoumon * Pregnant women and nursing mothers
Locations (30)
- Bad Saarow, Germany
- Berlin, Germany
- Bremen, Germany
- Cologne, Germany
- Dortmund, Germany
- Düsseldorf, Germany
- Eschweiler, Germany
- Essen, Germany
- Hagen, Germany
- Homburg, Germany
- Idar-Oberstein, Germany
- Karlsruhe, Germany
- Kiel, Germany
- Landshut, Germany
- Lemgo, Germany
- Limburg, Germany
- Magdeburg, Germany
- Meschede, Germany
- Mönchengladbach, Germany
- Munich, Germany
- Munich, Germany
- Mutlangen, Germany
- Oldenburg, Germany
- Paderborn, Germany
- Rostock, Germany
- Saarbrücken, Germany
- Sindelfingen, Germany
- Stuttgart, Germany
- Tübingen, Germany
- Ulm, Germany